510(k) K101212

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R by Medtronic, Inc. — Product Code KRH

K101212 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R". The FDA issued a decision of Substantially Equivalent on August 7, 2010. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Medtronic, Inc. has at least 10 other 510(k) clearances on record.